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Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty

This study has been completed.
Sponsor:
Collaborator:
University of Kuopio Computing Center
Information provided by:
North Karelia Central Hospital
ClinicalTrials.gov Identifier:
NCT00642200
First received: March 18, 2008
Last updated: May 20, 2008
Last verified: May 2008
  Purpose
The study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications.

Condition Intervention
Recurrent Inguinal Hernia
Procedure: Lichtenstein hernioplasty
Procedure: Laparoscopic TEP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lichtenstein Hernioplasty Versus Totally Extraperitoneal Laparoscopic Hernioplasty in Treatment of Recurrent Inguinal Hernia - A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by North Karelia Central Hospital:

Primary Outcome Measures:
  • further recurrence [ Time Frame: 3 weeks, 1 year, 2 years, 3 years ]

Secondary Outcome Measures:
  • chronic pain or discomfort [ Time Frame: 3 weeks, 1 year, 2 years, 3 years ]

Enrollment: 100
Study Start Date: January 1997
Study Completion Date: April 2007
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients receive Lichtenstein hernioplasty as a treatment for recurrent inguinal hernia.
Procedure: Lichtenstein hernioplasty
Active Comparator: 2
Patients receive laparoscopic TEP as a treatment for recurrent inguinal hernia.
Procedure: Laparoscopic TEP

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • recurrent inguinal hernia
  • willing to participate

Exclusion Criteria:

  • unwilling to participate
  • bilateral hernia
  • preference towards either treatment arm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642200

Locations
Finland
North Karelia Central Hospital - Clinic of Surgery
Joensuu, North Karelia, Finland, FI-80210
Sponsors and Collaborators
North Karelia Central Hospital
University of Kuopio Computing Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MD Sanna Kouhia, North Karelia Central Hospital, Clinic of Surgery
ClinicalTrials.gov Identifier: NCT00642200     History of Changes
Other Study ID Numbers: NKCH-surg-001
Study First Received: March 18, 2008
Last Updated: May 20, 2008

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 25, 2017